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A study on the treatment of chronic hepatitis B based on dendritic cells transduced with recombinant adeno-associated virus

A clinical study on the treatment of hepatitis B virus e antigen positive chronic hepatitis B patients with specific cytotoxic T lymphocyte induced by recombinant adeno-associated virus vector delivery into autologous dendritic cells with different hepatitis B virus genes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17011620
Enrollment
Unknown
Registered
2017-06-10
Start date
2017-07-01
Completion date
Unknown
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Interventions

Treatment Group:Specific Cytotoxic T Lymphocytes (CTLs) Induced by Autologous Dendritic Cells(DCs) Transduced With Adeno-associated Virus(AAV) Carrying Different Hepatitis B Virus (HBV) Antigen Gene F

Sponsors

Chongqing Three Gorges Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female, 18 Years to 70 Years at the time of signing informed consent; 2. Genotype C hepatitis B patients, HBsAg and HBeAg positive for more than 6 months; 3. The load of hepatitis B virus DNA was lower than 5x10^2 IU/ml in subjects being treated with nucleos(t)ide analogue; 4. subjects volunteered to join, and signed the informed consent before treatment.

Exclusion criteria

Exclusion criteria: 1. Co-infected with other hepatitis virus (including HCV, HAV, HDV, HEV) or HIV 2. Decompensated liver disease 3. autoimmune diseases 4. ALT or AST> 10 ULN, or total bilirubin > 2 mg/dL 5. Hepatocellular carcinoma (HCC) or other malignant tumors; 6. T cell lymphoma; 7. Severe infection within past 2 weeks; 8. Allergy to biological agents such as granulocyte colony-stimulating factor; 9. Undergoing systemic radiotherapychemotherapy or immunosuppressive agents; 10. Blood routine was significantly abnormal: the total number of white blood cells was lower than 3.5x10^9, and the hemoglobin was less than 110g/L; 11. Subjects or his/her family members with a history of seizures or psychiatric disability 12. Clinically significant renal, respiratory, cerebral, cardiovascular or endocrine disease such as?severe thyroid dysfunction 13. Pregnancy and lactation 14. Voluntarily withdrew from the study; 15. Drug addicts or alcoholism 16. One or more additional known primary or secondary causes of liver disease, e.g., alcohol-induced hepatitisdrug-induced hepatitisautoimmune hepatitishemochromatosisalpha-1 antitrypsin deficiency, Wilson's Disease, Gilbert's syndrome, Dubin-Johnson syndrome and other reasons considered to be exclused by the investigator.

Design outcomes

Primary

MeasureTime frame
safety;HBeAg;

Countries

China

Contacts

Public ContactWu Guicheng

Chongqing Three Gorges Central Hospital

351094703@qq.com+86 13896208811

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026